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This paper argues that the convention of allocating donated gametes on a “first come, first served” basis should be replaced with an allocation sys-tem that takes into account more morally relevant criteria than waiting time. This conclusion was developed using an empirical bioethics method-ology, which involved a study of the views of eighteen staff members from seven UK fertility clinics, and twenty academics, policy-makers, representa-tives of patient groups, and other relevant professionals, on the allocation of donated sperm and eggs. Against these views, we consider some nu-anced ways of including criteria in a points allocation system. We argue that such a system is more ethically robust than “first come, first served”, but we acknowledge that our results suggest that a points system will meet with resistance from those working in the field. We conclude that criteria such as a patient’s age, potentially damaging substance use, and parental status should be used to allocate points and determine which patients re-ceive treatment and in what order. These and other factors should be ap-plied according to how they bear on considerations like child welfare, pa-tient welfare, and the effectiveness of the proposed treatment.

In "A Conceptual Model for the Translation of Bioethics Research and Scholarship," Debra Mathews et al. aim to "begin an important discussion" about how to measure success in bioethics, and in doing so they set out a typology of bioethics research and scholarship with the arguably correct assumption that we cannot evaluate success in bioethics without first understanding what its goals are. I think the authors are correct in their claim that, in the current academic climate, having work in bioethics deemed a success is likely to hinge, in some way, on its being translated into practice and having impact. I want, however, to add a critical voice in the form of three considerations that I feel ought to be attended to before the work progresses further, the first being that the typology Mathews et al. propose is highly problematic. Although there is a burgeoning literature on "empirical bioethics" methodologies that blend empirical and conceptual work, the typology appears to ignore this.

The use of charged-particle radiation therapy (CPRT) is an increasingly important development in the treatment of cancer. One of the most pressing controversies about the use of this technology is whether randomised controlled trials are required before this form of treatment can be considered to be the treatment of choice for a wide range of indications. Equipoise is the key ethical concept in determining which research studies are justified. However, there is a good deal of disagreement about how this concept is best understood and applied in the specific case of CPRT. This report is a position statement on these controversies that arises out of a workshop held at Wolfson College, Oxford in August 2011. The workshop brought together international leaders in the relevant fields (radiation oncology, medical physics, radiobiology, research ethics and methodology), including proponents on both sides of the debate, in order to make significant progress on the ethical issues associated with CPRT research. This position statement provides an ethical platform for future research and should enable further work to be done in developing international coordinated programmes of research. Refereed/Peer-reviewed

ObjectivesPatient-reported outcome measures (PROMs) collected in clinical trials should be administered in a standardised way across sites and routinely screened for avoidable missing data in order to maximise data quality/minimise risk of bias. Recent qualitative findings, however, have raised concerns about the consistency of PROM administration in UK trials. The purpose of this study was to determine the generalisability of these findings across the wider community of trial personnel. DesignOnline cross-sectional survey. SettingParticipants were recruited from 55 UK Clinical Research Collaboration Registered Clinical Trials Units and 19 Comprehensive Local Research Networks.ParticipantsResearch nurses, data managers/coordinators, trial managers and chief/principal investigators involved in clinical trials collecting PROMs.AnalysisWe undertook descriptive analyses of the quantitative data and directed thematic analysis of free-text comments. Factors associated with the management of missing PRO data were explored using logistic regression.ResultsSurvey data from 767 respondents supported the generalisability of qualitative study findings, suggesting inconsistencies in PROM administration with regard to: the level of assistance given to trial participants; the timing of PROM completion in relation to the clinical consultation; and the management of missing data. Having ≥10 years experience in a research role was significantly associated with the appropriate management of missing PROM data (Odds ratio 2.26 (95% CI 1.06 to 4.82), p=.035). There was a consensus that more PROM guidance was needed in future trials and agreement between professional groups about the necessary components.ConclusionsThere are inconsistencies in the way PROMs are administered by trial staff. Such inconsistencies may reduce the quality of data and have the potential to introduce bias. There is a need for improved guidance in future trials that support trial personnel in conducting optimal PROM data collection to inform patient care.

In this short, rhetorical article, I offer a thought experiment that seeks to make an analogy between 'life' and 'disease'. This article was written whilst under the influence of Nietzsche, and I hope that readers will not mistake the polemical style and the occasional nod towards humour for flippancy. This is a serious subject, and this article attempts to ask, inexplicitly, a serious question. If we do suspend our subjective value judgements about life, and strip away what might be considered the 'dogma' of value in life, what effect might this have on our feelings towards voluntary euthanasia, and what can our reaction to that thought experiment tell us?

Objectives We aimed to (1) evaluate the extent to which doctors in New Zealand would be willing to answer honestly questions about their care of patients at the end of their lives and (2) identify the assurances that would encourage this. Results were compared with findings from a previous pilot study from the UK. Design Survey study involving a mailed questionnaire. Setting New Zealand hospital and community-based medical care settings. Participants The questionnaire was mailed to a random sample of 800 doctors in New Zealand who were vocationally registered with the Medical Council of New Zealand in disciplines involving caring for patients at the end of their lives. Primary and secondary outcome measures Willingness to provide honest answers about various aspects of end-of-life care; assurances that might increase willingness to provide honest answers to questions about end-of-life practices. Results Completed questionnaires were returned by 436 doctors. The majority of respondents (59.9–91.5%) indicated willingness to provide honest answers to such questions. However, more than a third of doctors were unwilling to give honest answers to certain questions regarding euthanasia. These results are comparable with the UK data. Complete anonymity was the assurance most likely to encourage honest answering, with most of the respondents preferring the use of anonymous written replies. Respondents were less reassured by survey endorsements from regulatory bodies. Themes in free comments included the deterrent effect of medicolegal consequences, fear of censure from society, peers and the media and concerns about the motivations and potential uses of such research. Conclusions Many New Zealand doctors were willing to give honest answers to questions about end-of-life practices, particularly if anonymity was guaranteed; others, however, expressed doubts or indicated that they would not be willing to provide honest answers to questions of this sort.

Background The rationale for centre selection in randomised controlled trials (RCTs) is often unclear but may have important implications for the generalisability of trial results. The aims of this study were to evaluate the factors which currently influence centre selection in RCTs and consider how generalisability considerations inform current and optimal practice. Methods and Findings Mixed methods approach consisting of a systematic review and meta-summary of centre selection criteria reported in RCT protocols funded by the UK National Institute of Health Research (NIHR) initiated between January 2005-January 2012; and an online survey on the topic of current and optimal centre selection, distributed to professionals in the 48 UK Clinical Trials Units and 10 NIHR Research Design Services. The survey design was informed by the systematic review and by two focus groups conducted with trialists at the Birmingham Centre for Clinical Trials. 129 trial protocols were included in the systematic review, with a total target sample size in excess of 317,000 participants. The meta-summary identified 53 unique centre selection criteria. 78 protocols (60%) provided at least one criterion for centre selection, but only 31 (24%) protocols explicitly acknowledged generalisability. This is consistent with the survey findings (n = 70), where less than a third of participants reported generalisability as a key driver of centre selection in current practice. This contrasts with trialists’ views on optimal practice, where generalisability in terms of clinical practice, population characteristics and economic results were prime considerations for 60% (n = 42), 57% (n = 40) and 46% (n = 32) of respondents, respectively. Conclusions Centres are rarely enrolled in RCTs with an explicit view to external validity, although trialists acknowledge that incorporating generalisability in centre selection should ideally be more prominent. There is a need to operationalize ‘generalisability’ and incorporate it at the design stage of RCTs so that results are readily transferable to ‘real world’ practice.

Background An empirical bioethics analysis exploring what palliative inpatients understand as compassion was planned within an Intercalated BMedSc degree. Limited time was available, so to achieve deadlines, a co-developmental approach was employed maximising clinical/research expertise from hospice and university. Aim To study compassion by forming an effective university-hospice research partnership. Methods A multi-disciplinary research team (MDRT) was created comprising a student, academic researcher, hospice nurse and hospice facilitator. Introductory meetings in January 2016 developed a research strategy appropriate to a hospice inpatient unit (IPU). Three members of the MDRT attended the IRAS committee and on-going support ensured governance permissions were obtained. Recruitment over 8 weeks (March–May 2016) was designed to be symbiotic with clinical care, promoting a good experience of exploratory qualitative interviewing. Results and discussion Intense support of the researcher facilitated timely transition through governance. All IPU patients were screened. Nineteen eligible patients were approached and introduced to the study by the nurse who also communicated with the clinical care teams. Six patients were consented by the student and 15–25 minute semi-structured interviews were conducted. Reasons for non-participation varied from feeling tired or poorly to exclusive interest in interventional research trials. Conclusion A MDRT approach can facilitate a qualitative research study in an inpatient hospice. Knowledge of the clinical setting maximised an effective recruitment strategy. Recruitment barriers included time constraints, patient willingness, patient availability, and perceptions of patient capacity and willingness. Ethics and procedural questions around promoting compassion research participation in this potentially vulnerable population can be addressed. Reference Byrne A, Upton L, Townsend S. Mind the gap: a step forward in supporting hospice-based research. BMJ Support Palliat Care 2014;5(1):4–6. doi:10.1136/bmjspcare-2014-000808

Background As agency and capacity decline towards the end of life, compassion becomes an increasingly important and apposite feature of healthcare. Whilst more compassionate healthcare is being called for, especially in end of life contexts, there is relatively little understanding of what compassion actually is, or how it can be enacted. Aim To conduct an empirical bioethics analysis to explore the concept of compassion and how this is understood by patients, in order to inform an ethical analysis of how compassion ought to be conceived and performed in end of life care (EOLC). Methods An exploratory qualitative approach underpinned by Frith’s Symbiotic Empirical Ethics methodology was used. Six semi-structured interviews were conducted in a UK hospice. Results and discussion Compassion was conceived in different ways by different participants, but 6 key themes emerged that patient’s identified as essential to a compassionate experience: ‘caring motivation’, ‘attentive acts’, ‘caring what I care about’, ‘being relational’, ‘response to suffering’ and ‘time.’ However, these themes are not all compatible. Consequently, each constituent of compassion was explored; examining whether each was necessary for an acceptable definition of compassion. From this analysis, a conceptualisation of compassion in EOLC was developed that focuses on compassion being relational, centred on performing attentive individualistic acts. Conclusion Compassionate care should be based on an individual patient’s needs, and this study acts as a reminder that compassionate acts need not be lengthy. Moreover, compassion is a holistic concept, should be treated as such. Finally, through attentive practice, compassion can be ‘learned’. References Bramley L, Matiti M. How does it really feel to be in my shoes? Patients’ experiences of compassion within nursing care and their perceptions of developing compassionate nurses. J Clin Nurs 2014; 23 (19–20):2790–2799 Dewar B, Adamson E, Smith S, et al . Clarifying misconceptions about compassionate care. J Adv Nurs 2013; 70 (8): 1738–1747 Frith L. Symbiotic empirical ethics: a practical methodology. Bioethics 2012; 26 (4):198–206 Wenrich MD, Curtis JR, Ambrozy DA, et al. Dying patients’ need for emotional support and care from physicians: perspectives of patients with terminal illness, families, and health care providers. J Pain Symptom Manage 2003; 25 (3):236–246

Background Patient reported outcomes (PROs) are increasingly assessed in clinical trials, and guidelines are available to inform the design and reporting of such trials. However, researchers involved in PRO data collection report that specific guidance on ‘in-trial’ activity (recruitment, data collection and data inputting) and the management of ‘concerning’ PRO data (i.e., data which raises concern for the well-being of the trial participant) appears to be lacking. The purpose of this review was to determine the extent and nature of published guidelines addressing these areas. Methods and Findings Systematic review of 1,362 articles identified 18 eligible papers containing ‘in-trial’ guidelines. Two independent authors undertook a qualitative content analysis of the selected papers. Guidelines presented in each of the articles were coded according to an a priori defined coding frame, which demonstrated reliability (pooled Kappa 0.86–0.97), and validity (

Background/Objectives: Every year, over 1,300 women in the UK suffer a psychotic episode following childbirth. Known as ‘postpartum psychosis’ or ‘puerperal psychosis', these episodes onset suddenly in the days after having a baby and can be a frightening experience for women, their partners, friends and family. Despite good clinical recovery, women report that coming to terms with the experience is a lengthy process. Pilot work found that recovering women search the internet for information but find it limited, misleading or sensationalist. The objective of this study was to explore the experience of women with postpartum psychosis in different service settings such as psychiatric Mother and Baby Units and general psychiatric wards. Methods: Five women from ‘Action on Postpartum Psychosis’ who had expressed an interest in learning about research, took part in a workshop in qualitative research methodology. On day one, training in theory and interview skills was provided. On day two, a study was designed collaboratively and topic guide questions determined. Service user researchers then conducted in-depth interviews with each other about their experiences of postpartum psychosis and recovery. Interviews were recorded and transcribed by a service user researcher with experience of transcription. Data analysis was conducted by a team of two service user researchers, a perinatal researcher and two qualitative researchers using a grounded analytic induction approach. Thematic validation was carried out by the other service user researchers. Results: Seven broad categories emerged: Unmet Expectations; Ordering and Rationalising; Social Interaction; Medical Support; Family Support; Information; Small Steps and Time. Web-based information on assisting recovery from postpartum psychosis was developed. Discussion/Conclusions: Project outputs include a YouTube film, academic papers and web-based leaflets to address the need for accessible information on this condition and available mental health services.

A wide range of self-tests are available where contact with a health professional is not necessary.To investigate factors that influenced members of the public to use self-tests.Questionnaires, sent to 2335 adults from two general practices in North Birmingham, asked whether recipients had used self-tests and sought consent for contacting them about taking part in an interview. Twenty-three people were interviewed, 20 of whom had used self-tests. The interviews were transcribed verbatim, and a thematic analysis was conducted.The findings were organized around two themes. 'Motivations for self-testing' describes the motivating factors surrounding participants' choices to use self-tests. This appeared to be influenced by a number of factors that were organized into four sub-themes: 'diagnosis or speculation', 'perceived benefits of self-testing', 'general attitudes to and experiences of health care' and 'general attitudes to health'. The second theme called 'experience of self-testing' describes participants' access to, and use of self-tests, and is split into three sub-themes: 'opportunistic awareness and access', 'use and application' and 'impact on life'.Overall, self-testing encompasses a broad variety of beliefs and experiences. Some participants saw self-tests as a serious diagnostic tool, whereas others used them out of simple curiosity. Some were motivated by their generally positive attitude to health, but others may have been motivated by negative health care experiences. Some saw self-testing as an empowering process to be proud of, while others seemed to view it as an illegitimate activity that needed to be hidden from professionals.

This chapter examines a risk scenario that could form one of the most significant communication challenges both nationally and globally: an influenza pandemic. A pandemic occurs when a new influenza strain emerges and spreads rapidly because people have no natural resistance to it. Drawing upon the evidence gathered from healthcare workers — who might plausibly have an enhanced understanding of the potential risks — the chapter considers how information and knowledge might be exchanged amongst the wider public. This should help in understanding how risk communication efforts might most effectively engage with people, before (as well as during) an outbreak. Before outlining this evidence, the characteristics of pandemic influenza that may impact on people's understanding, information needs, and response are summarized.

Background Healthcare workers (HCWs) will play a key role in any response to pandemic influenza, and the UK healthcare system's ability to cope during an influenza pandemic will depend, to a large extent, on the number of HCWs who are able and willing to work through the crisis. UK emergency planning will be improved if planners have a better understanding of the reasons UK HCWs may have for their absenteeism, and what might motivate them to work during an influenza pandemic. This paper reports the results of a qualitative study that explored UK HCWs' views (n = 64) about working during an influenza pandemic, in order to identify factors that might influence their willingness and ability to work and to identify potential sources of any perceived duty on HCWs to work. Methods A qualitative study, using focus groups (n = 9) and interviews (n = 5). Results HCWs across a range of roles and grades tended to feel motivated by a sense of obligation to work through an influenza pandemic. A number of significant barriers that may prevent them from doing so were also identified. Perceived barriers to the ability to work included being ill oneself, transport difficulties, and childcare responsibilities. Perceived barriers to the willingness to work included: prioritising the wellbeing of family members; a lack of trust in, and goodwill towards, the NHS; a lack of information about the risks and what is expected of them during the crisis; fear of litigation; and the feeling that employers do not take the needs of staff seriously. Barriers to ability and barriers to willingness, however, are difficult to separate out. Conclusion Although our participants tended to feel a general obligation to work during an influenza pandemic, there are barriers to working, which, if generalisable, may significantly reduce the NHS workforce during a pandemic. The barriers identified are both barriers to willingness and to ability. This suggests that pandemic planning needs to take into account the possibility that staff may be absent for reasons beyond those currently anticipated in UK planning documents. In particular, staff who are physically able to attend work may nonetheless be unwilling to do so. Although there are some barriers that cannot be mitigated by employers (such as illness, transport infrastructure etc.), there are a number of remedial steps that can be taken to lesson the impact of others (providing accommodation, building reciprocity, provision of information and guidance etc). We suggest that barriers to working lie along an ability/willingness continuum, and that absenteeism may be reduced by taking steps to prevent barriers to willingness becoming perceived barriers to ability.

Recruitment to primary care-based studies may occur within the consultation or in dedicated research clinics. For practical and logistic reasons, some patients are recruited to research studies by their family doctor during the consultation. However, this may preclude patients from discussing participation with others and some patients may not feel empowered to refuse participation. This may be a particular problem when patients have their own family doctor, whom they generally see, and the patient feels dependent on their practitioner's goodwill for ongoing care. Recruitment within the practice, therefore, raises ethical issues that warrant further exploration. This discussion article argues that there are reasons to suppose there may be problems associated with family doctors recruiting their own patients into research. Nevertheless, assumptions that patients feel undue pressure or obligation to participate in primary care research may not be justified. It is important that potential research participants have time to consider the implications of participation. However, the risks to patients of consenting to participate in research are, in many instances, less than the risks inherent in their routine treatment. We conclude that it is important that those responsible for the implementation of research ethics approvals and governance procedures are careful to avoid imposing inflexible rules that prevent patients from acting according to their own wishes.

Medical student learning is dependent on an unwritten agreement between patients and the medical profession, in which students "practise" upon real patients in order that, when they are doctors, those same patients will benefit from the doctors' skills. Given the increasing propensity for patients to refuse to take part in such learning, there is a danger that doctors will qualify without being truly competent. As patients, we must all ask ourselves, when asked to take part in medical teaching: if this student/trainee doesn't learn now, on me and under supervision, how will the person be truly competent next time, when this is for real, and the patient might be me or my loved one? We argue that a new and more explicit agreement is needed, in which the default should be that all patients are willing to help in the education of medical students, while we ensure that all such students are already competent in simulation before first practising upon real patients.

Background Healthcare workers (HCWs) will be key players in any response to pandemic influenza, and will be in the front line of exposure to infection. Responding effectively to a pandemic relies on the majority of medical, nursing, laboratory and hotel services staff continuing to work normally. Planning assumes that during a pandemic normal healthcare service levels will be provided, although it anticipates that as caseloads increase only essential care will be provided. The ability of the NHS to provide expected service levels is entirely dependent upon HCWs continuing to work as normal. Methods/design This study is designed as a two-phase multi-method study, incorporating focus groups and a questionnaire survey. In phase one, qualitative methods will be used to collect the views of a purposive sample of HCWs, to determine the range of factors associated with their responses to the prospect of working through pandemic influenza. In phase two, the findings from the focus groups, combined with the available literature, will be used to inform the design of a survey to determine the generalisability of these factors, enabling the estimation of the likely proportion of HCWs affected by each factor, and how likely it is that they would be willing and/or able to continue to work during an influenza pandemic. Discussion There are potentially greater than normal health risks for some healthcare workers working during a pandemic, and these workers may be concerned about infecting family members/friends. HCWs will be as liable as other workers to care for sick family members and friends. It is vital to have information about how motivated HCWs will be to continue to work during such a crisis, and what factors might influence their decision to work/not to work. Through the identification and subsequent management of these factors it may be possible to implement strategies that will alleviate the concerns and fears of HCWs and remove potential barriers to working.

A hitherto unexamined problem for the "Kantian ideal" that one should always treat patients as ends in themselves, and never only as a means to other ends, is explored in this paper. The problem consists of a prima facie conflict between this Kantian ideal and the reality of medical practice. This conflict arises because, at least presently, medical practitioners can only acquire certain skills and abilities by practising on live, human patients, and given the inevitability and ubiquity of learning curves, this learning requires some patients to be treated only as a means to this end. A number of ways of attempting to establish the compatibility of the Kantian Ideal with the reality of medical practice are considered. Each attempt is found to be unsuccessful. Accordingly, until a way is found to reconcile them, we conclude that the Kantian ideal is inconsistent with the reality of medical practice.

Introduction Evidence suggests that the subjective experience of AVHs cannot be explained by any of the existing cognitive models,[1] highlighting the obvious need to properly investigate the actual, lived experience of AVHs, and derive models/theories that fit the complexity of this. Objectives Via phenomenological interviews and ethnographic diary methods, we aim to gain a deeper insight into the experience of AVHs. Aims To explore the phenomenological quality of AVHs, as they happen/reveal themselves to consciousness, [2] [3] without relying on existing suppositions. Methods Participants with First Episode Psychosis were recruited from the Birmingham Early Intervention Service (EIS), BSMHFT. In-depth 'walking interviews' were carried out with each participant, together with standardised assessment measures of voices. Prior to interviews, participants were asked to complete a dairy and take photographs, further capturing aspects of their AVH experiences. Results 20 participants have completed interviews to date. Emerging themes cover the form and quality of voices (i.e. as being separate to self, imposing, compelling etc.), and participants' understanding and management of these experiences. Conclusions Authentic descriptions gleaned from participants have the potential to increase our understanding of the relationship between the phenomenology and neurobiology of AVHs and, in turn, the experience as a whole.

What follows is partly informed by the findings of a study we carried out to investigate the attitudes of National Health Service (NHS) employees in the West Midlands, United Kingdom (UK), towards ...

[⇓][1] ![Figure][2] ‘Empirical bioethics’ aims to combine philosophical analysis with empirical data to produce ethical analyses that are sensitive to and informed by practice, practitioners and patients. There is, however, disagreement about how this can be achieved. Empirical

Background If UK healthcare services are to respond effectively to pandemic influenza, levels of absenteeism amongst healthcare workers (HCWs) must be minimised. Current estimates of the likelihood that HCWs will continue to attend work during a pandemic are subject to scientific and predictive uncertainty, yet an informed evidence base is needed if contingency plans addressing the issues of HCW absenteeism are to be prepared. Methods This paper reports the findings of a self-completed survey of randomly selected HCWs across three purposively sampled healthcare trusts in the West Midlands. The survey aimed to identify the factors positively or negatively associated with willingness to work during an influenza pandemic, and to evaluate the acceptability of potential interventions or changes to working practice to promote the continued presence at work of those otherwise unwilling or unable to attend. 'Likelihood' and 'persuadability' scores were calculated for each respondent according to indications of whether or not they were likely to work under different circumstances. Binary logistic regression was used to compute bivariate and multivariate odds ratios to evaluate the association of demographic variables and other respondent characteristics with the self-described likelihood of reporting to work. Results The survey response rate was 34.4% (n = 1032). Results suggest absenteeism may be as high as 85% at any point during a pandemic, with potential absence particularly concentrated amongst nursing and ancillary workers (OR 0.3; 95% CI 0.1 to 0.7 and 0.5; 95% CI 0.2 to 0.9 respectively). Conclusion Levels of absenteeism amongst HCWs may be considerably higher than official estimates, with potential absence concentrated amongst certain groups of employees. Although interventions designed to minimise absenteeism should target HCWs with a low stated likelihood of working, members of these groups may also be the least receptive to such interventions. Changes to working conditions which reduce barriers to the ability to work may not address barriers linked to willingness to work, and may fail to overcome HCWs' reluctance to work in the face of what may still be deemed unacceptable risk to self and/or family.

Background Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem. Methods And Findings We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden. Conclusions Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting researchers to carry out high quality data collection.